Table 2.
Change in body composition and metabolic risk factors after 3 months intervention among participants
| LCD |
p value | TRE |
p value | Both |
p value | p value for pairwise comparison |
||||
|---|---|---|---|---|---|---|---|---|---|---|
| N = 55 | N = 55 | N = 52 | LCD vs. TRE | LCD vs. Both | TRE vs. Both | |||||
| Days of adherence (days) | – | 55.5 ± 3.5 | – | 65.9 ± 3.0 | – | 57.7 ± 3.1 | – | 0.024 | 0.631 | 0.059 |
| Willingness to continue the diet (n/total, %) | – | 46/47 (98) | – | 43/44 (98) | – | 36/44 (82) | – | 0.962 | 0.010 | 0.014 |
| Meal-eating window (hours) | Follow-up | 10.0 ± 0.3 | – | 6.5 ± 0.3 | – | 6.8 ± 0.3 | – | – | – | – |
| △ | −0.6 ± 0.3 | 0.075 | −3.9 ± 0.4 | < 0.001 | −3.9 ± 0.4 | < 0.001 | < 0.001 | < 0.001 | 0.992 | |
| Daily carbohydrate intake (g) | Follow-up | 149 ± 12 | – | 327 ± 15 | – | 140 ± 11 | – | – | – | – |
| △ | −175 ± 22 | < 0.001 | −21 ± 14 | 0.137 | −221 ± 20 | < 0.001 | < 0.001 | 0.125 | < 0.001 | |
| Weight a (kg) | 1 M Follow-up | 83.0 ± 2.2 | – | 82.6 ± 2.1 | – | 82.1 ± 1.8 | – | – | – | – |
| 1 M △ | −1.7 ± 0.3 | < 0.001 | −2.4 ± 0.4 | < 0.001 | −2.6 ± 0.4 | < 0.001 | 0.116 | 0.082 | 0.768 | |
| 2 M Follow-up | 82.2 ± 2.2 | – | 81.4 ± 2.0 | – | 80.5 ± 1.8 | – | – | – | – | |
| 2 M △ | −2.5 ± 0.3 | < 0.001 | −3.7 ± 0.4 | < 0.001 | −4.2 ± 0.4 | < 0.001 | 0.015 | 0.002 | 0.347 | |
| 3 M Follow-up | 82.3 ± 2.4 | – | 81.2 ± 2.2 | – | 80.2 ± 1.8 | – | – | – | – | |
| 3 M △ | −2.2 ± 0.3 | 0.213 | −3.4 ± 0.4 | 0.323 | −5.0 ± 0.4 | 0.028 | 0.013 | <0.001 | 0.004 | |
| BMI (kg/m2) | Follow-up | 28.3 ± 0.4 | – | 28.1 ± 0.4 | – | 27.2 ± 0.4 | – | – | – | – |
| △ | −0.9 ± 0.2 | < 0.001 | −1.4 ± 0.3 | < 0.001 | −1.8 ± 0.2 | < 0.001 | 0.098 | 0.003 | 0.280 | |
| Waist circumference (cm) | Follow-up | 93.6 ± 1.6 | – | 92.7 ± 1.5 | – | 91.4 ± 1.4 | – | – | – | – |
| △ | −2.4 ± 1.1 | 0.035 | −4.2 ± 1.0 | < 0.001 | −3.3 ± 1.2 | 0.008 | 0.248 | 0.603 | 0.563 | |
| Hip circumference (cm) | Follow-up | 102.3 ± 0.9 | – | 103.0 ± 0.9 | – | 100.9 ± 1.0 | – | – | – | – |
| △ | −2.7 ± 0.8 | 0.001 | −1.5 ± 0.7 | 0.046 | −2.8 ± 0.9 | 0.002 | 0.263 | 0.945 | 0.267 | |
| Waist-to-hip ratio (WHR) | Follow-up | 0.91 ± 0.01 | – | 0.90 ± 0.01 | – | 0.90 ± 0.01 | – | – | – | – |
| △ | −0.01 ± 0.01 | 0.421 | −0.04 ± 0.01 | < 0.001 | −0.01 ± 0.01 | 0.493 | 0.023 | 0.994 | 0.033 | |
| Body fat mass (kg) | Follow-up | 31.9 ± 0.9 | – | 31.9 ± 0.9 | – | 29.8 ± 0.9 | – | – | – | – |
| △ | −2.0 ± 0.4 | < 0.001 | −1.3 ± 0.6 | 0.028 | −3.0 ± 0.5 | < 0.001 | 0.301 | 0.103 | 0.041 | |
| Body muscle mass (kg) | Follow-up | 31.3 ± 1.0 | – | 31.1 ± 0.9 | – | 31.5 ± 0.8 | – | – | – | – |
| △ | 0.1 ± 0.2 | 0.524 | −0.5 ± 0.3 | 0.046 | −0.5 ± 0.2 | 0.064 | 0.048 | 0.064 | 0.893 | |
| Subcutaneous fat area (SFA, cm2) | Follow-up | 253 ± 12 | – | 245 ± 10 | – | 231 ± 10 | – | – | – | – |
| △ | −23 ± 5 | < 0.001 | −24 ± 8 | 0.003 | −24 ± 8 | 0.006 | 0.927 | 0.988 | 0.949 | |
| Visceral fat area (VFA, cm2) | Follow-up | 98 ± 6 | – | 92 ± 5 | – | 86 ± 4 | – | – | – | – |
| △ | 6 ± 5 | 0.277 | −13 ± 5 | 0.008 | −10 ± 3 | 0.006 | 0.009 | 0.016 | 0.548 | |
| Hemoglobin A1c (HbA1c, %) | Follow-up | 5.7 (0.6) | – | 5.6 (0.6) | – | 5.6 (0.7) | – | – | – | – |
| △ | 0.0 (0.3) | 0.404 | 0.0 (0.3) | 0.385 | −0.1 (0.4) | 0.021 | 0.928 | 0.126 | 0.157 | |
| Fasting blood glucose (mmol/L) | Follow-up | 5.22 (1.11) | – | 4.76 (1.01) | – | 5.01 (1.23) | – | – | – | – |
| △ | 0.07 (0.81) | 0.820 | −0.18 (0.65) | 0.024 | −0.21 (0.96) | 0.048 | 0.102 | 0.113 | 0.739 | |
| Fasting insulin (mIU/L) | Follow-up | 23.7 (19.4) | – | 26.5 (20.3) | – | 18.2 (20.8) | – | – | – | – |
| △ | −3.1 (10.4) | < 0.001 | −3.3 (12.7) | < 0.001 | −5.5 (14.4) | < 0.001 | 0.394 | 0.319 | 0.781 | |
| C-peptide (pg/mL) | Follow-up | 1,424.1 ± 85.2 | – | 1,416.3 ± 80.3 | – | 1,332.7 ± 71.0 | – | – | – | – |
| △ | −184.6 ± 47.6 | < 0.001 | −243.9 ± 66.0 | 0.001 | −319.1 ± 67.8 | < 0.001 | 0.468 | 0.104 | 0.429 | |
| HOMA-IR | Follow-up | 4.64 (4.70) | – | 5.73 (4.39) | – | 4.17 (4.41) | – | – | – | – |
| △ | −1.15 (2.99) | < 0.001 | −1.04 (4.53) | < 0.001 | −2.16 (4.82) | < 0.001 | 0.427 | 0.049 | 0.258 | |
| HOMA-IS | Follow-up | 0.23 (0.29) | – | 0.22 (0.42) | – | 0.29 (0.21) | – | – | – | – |
| △ | 0.03 (0.12) | < 0.001 | 0.04 (0.25) | < 0.001 | 0.10 (0.20) | < 0.001 | 0.421 | 0.042 | 0.245 | |
| QUICKI | Follow-up | 0.31 (0.04) | – | 0.30 (0.04) | – | 0.31 (0.04) | – | – | – | – |
| △ | 0.01 (0.02) | 0.001 | 0.01 (0.03) | < 0.001 | 0.02 (0.03) | < 0.001 | 0.144 | 0.004 | 0.157 | |
| Uric acid (UA, μmol/L) | Follow-up | 363 ± 14 | – | 345 ± 12 | – | 364 ± 12 | – | – | – | – |
| △ | −17 ± 11 | 0.125 | −40 ± 9 | 0.001 | −51 ± 13 | < 0.001 | 0.146 | 0.039 | 0.259 | |
| Total cholesterol (mmol/L) | Follow-up | 4.91 ± 0.15 | – | 4.79 ± 0.14 | – | 4.87 ± 0.15 | – | – | – | – |
| △ | 0.19 ± 0.12 | 0.112 | 0.03 ± 0.17 | 0.866 | 0.14 ± 0.13 | 0.289 | 0.432 | 0.777 | 0.603 | |
| LDL-c (mmol/L) | Follow-up | 3.27 ± 0.14 | – | 3.14 ± 0.14 | – | 3.33 ± 0.15 | – | – | – | – |
| △ | 0.28 ± 0.13 | 0.042 | 0.13 ± 0.14 | 0.343 | 0.30 ± 0.13 | 0.026 | 0.447 | 0.929 | 0.389 | |
| Triglycerides (TG, mmol/L) | Follow-up | 1.30 (0.94) | – | 1.60 (1.64) | – | 1.40 (1.59) | – | – | – | – |
| △ | −0.15 (1.20) | 0.052 | −0.30 (1.36) | 0.006 | −0.51 (2.01) | < 0.001 | 0.363 | 0.011 | 0.160 | |
| HDL-c (mmol/L) | Follow-up | 1.16 ± 0.03 | – | 1.13 ± 0.03 | – | 1.13 ± 0.03 | – | – | – | – |
| △ | 0.03 ± 0.03 | 0.288 | 0.02 ± 0.03 | 0.442 | 0.09 ± 0.02 | < 0.001 | 0.869 | 0.136 | 0.109 | |
| TG/HDL-c | Follow-up | 1.20 (1.20) | – | 1.49 (1.54) | – | 1.30 (1.33) | – | – | – | – |
| △ | −0.02 (1.20) | 0.244 | −0.30 (1.59) | 0.024 | −0.59 (2.13) | < 0.001 | 0.265 | 0.003 | 0.094 | |
| Systolic blood pressure (mmHg) | Follow-up | 130 ± 3 | – | 137 ± 2 | – | 131 ± 2 | – | – | – | – |
| △ | 1 ± 2 | 0.770 | 1 ± 2 | 0.635 | 1 ± 2 | 0.719 | 0.923 | 0.979 | 0.914 | |
| Diastolic blood pressure (mmHg) | Follow-up | 81 ± 2 | – | 85 ± 2 | – | 80 ± 2 | – | – | – | – |
| △ | −1 ± 1 | 0.313 | −2 ± 1 | 0.144 | −5 ± 2 | 0.005 | 0.823 | 0.140 | 0.178 | |
LCD, low-carbohydrate diet; TRE, time-restricted eating; Both, combination treatment; BMI, body mass index; HOMA-IR, homeostasis model assessment insulin resistance; HOMA-IS, homeostatic model assessment of insulin sensitivity; QUICKI, quantitative insulin-sensitivity check index; LDL-c, low-density lipoprotein cholesterol; HDL-c, high-density lipoprotein cholesterol. All data were presented as mean ± standard error of the mean (SEM) for normally distributed variables or the median (interquartile range) for abnormal distribution. Change scores from baseline were represented by “Δ” in the table. Analyses were conducted using all participants (intention-to-treat), using a linear mixed model with randomized dietary intervention as factor to correct for the correlations of repeated measurements on changes in body weight, and using a multiple imputation approach for other missing data. After 3 months of intervention, pairwise comparisons of change scores between the groups (e.g., TRE vs. LCD, TRE vs. Both, LCD vs. Both) were evaluated by t test or Mann-Whitney U test. For weight a: significant differences compared with 1 month before (paired t test); for other parameters: significant differences compared with baseline (paired t test or paired Wilcoxon test).